Development Process Engineer

Title: Development Process Engineer Location: St. Paul, MN Duration: 12 Month 100% Onsite Primary Responsibilities Run design of experiments (DOE) studies to characterize processes and improve yield and efficiency Coach, mentor, and guide technicians, trainers, and operators Manage projects including new equipment, process improvements, cost reduction, and new product introduction support Conduct equipment qualifications and process validations Improve product quality, labor efficiency, and throughput using Lean manufacturing concepts and root cause tools (e.g., DMAIC) Coordinate Design, procurement, build, and debugging of tooling, machinery, and test equipment Work cross-functionally with R&D, Finance, Quality, and Operations to define process inputs and outputs Support company initiatives aligned with QMS, EMS, and regulatory requirements Ensure compliance with FDA regulations, company policies, and procedures while maintaining effective collaboration across stakeholders Skills Experience working in a broader enterprise/cross-division business unit model Ability to work both within a team and as an individual contributor Multitasking and ability to prioritize Strong written and verbal communication Strong organizational skills and attention to detail Result-driven mindset Duties Establish processes based on product specifications Evaluate process and design alternatives based on Design for Manufacturability principles Understand principles of Cost of Goods Sold Manage program compliance with Quality Control requirements (e.g., Design Control, Process Validation) Understand IP issues relative to processes being developed Maintain knowledge of manufacturing and design technologies Understand work environment issues (e.g., OSHA regulations) Support divisional initiatives aligned with Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements Ensure compliance with FDA regulations, company policies, operating procedures, and task assignments Maintain positive and cooperative communication with employees, customers, contractors, and vendors Required Qualifications Bachelor of Science in Engineering or Technical Field, or an equivalent combination of education and work experience 5+ years manufacturing engineering experience in medical device or related industry, including documenting process improvement initiatives Strong verbal and written communication skills across organizational levels Experience in a highly matrixed and geographically diverse environment Strong analytical, problem-solving, and project management skills Strong organizational, follow-up skills, and attention to detail Ability to work independently with minimal direction Proficient in MS Office (Word, Excel, Outlook, PowerPoint) Preferred Qualifications Medical device experience Experience collaborating closely with R&D Experience in delivery system design, yield improvement, cost reduction, and capacity increase Lean Six Sigma Green or Black Belt certification Consultants Eligible Benefits Upon Waiting Period Medical and Prescription Drug Plans Dental Plan Vision Plan Health Savings Account (for High-Deductible Health Plans) Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit) Supplemental Life Insurance Short Term Disability (coverage varies by state) Long Term Disability Critical Illness, Hospital coverage, Accident Insurance MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance 401(k) #J-18808-Ljbffr